Desonide

INDICATIONS AND USAGE Desonide ointment USP, 0.05% is a low potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. It should not be used for longer than two weeks unless directed by a physician.

DOSAGE AND ADMINISTRATION Desonide ointment USP, 0.05% should be applied to the affected area as a thin film from two to four times daily depending on the severity of the condition. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within two weeks, reassessment of diagnosis may be necessary. Desonide ointment USP, 0.05% should not be used with occlusive dressings.

CONTRAINDICATIONS Desonide ointment USP, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

ADVERSE REACTIONS In controlled clinical trials, the total incidence of adverse reactions associated with the use of desonide ointment USP, 0.05% was approximately 6%. These adverse reactions were erythema, induration, pruritus, irritation, oiliness, and peripheral edema. The following additional local adverse reactions have been reported infrequently with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions are listed in approximate decreasing order of occurrence: dryness, folliculitis, acneiform eruptions, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, miliaria, burning and hypopigmentation. To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals, Inc. at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

DESCRIPTION Desonide Ointment, 0.05% contains desonide (Pregna-1,4-diene-3,20-dione,11,21-dihydroxy-16,17- [(1-methylethylidene)bis(oxy)]-,(11β,16α-)) a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primary synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, desonide, the active ingredient in Desonide Ointment, 0.05%, is C 24 H 32 O 6 . It has the following structural formula: The molecular weight of desonide is 416.51. It is a white to off-white odorless powder which is soluble in methanol and practically insoluble in water. Each gram of Desonide Ointment, 0.05% contains 0.5 milligram of desonide in an ointment base consisting of mineral oil and white petrolatum. It is a smooth, uniform petrolatum-type ointment. Chemical Structure

OVERDOSAGE Topically applied desonide ointment USP, 0.05% can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS ).

HOW SUPPLIED Desonide Ointment, 0.05% is supplied in 15 g tubes (NDC 72603-164-01) and 60 g tubes (NDC 72603-164-02). STORAGE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing.